Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OCT-guided PCI
Angiography-guided PCI
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Optical coherence tomography, antiplatelet therapy
Eligibility Criteria
Inclusion criteria
- Age 19-85 years
- Patients with ischemic heart diseases (including stable angina, unstable angina and acute myocardial infarction) presented with typical chest pain or objective evidences of myocardial ischemia (positive invasive or non-invasive studies, electrocardiogram (ECG) consistent with ischemia, or elevated cardiac enzymes)
- Complex coronary stenotic lesions (>50% based on visual estimate) considered for coronary revascularization with DES
Definition of complex lesions (at least one):
- Acute myocardial infarction
- Chronic total occlusion
- Long lesion: expected stent length ≥28mm based on angiographic estimation
- Calcified lesion
- Bifurcation (including all techniques, one- or two-stent)
- Unprotected left main disease
- Small vessel diseases with reference vessel diameter less than 2.5 mm
- Intracoronary thrombus visible on the angiography
- Stent thrombosis
- In-stent restenosis
- Patients who provide signed informed consent
Exclusion criteria
- Severe hepatic dysfunction (≥3 times normal reference values)
- Significant renal dysfunction (Serum creatinine >2.0 mg/dL)
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a white blood cell count of <3,000 cells/mm3, hemoglobin <8.0 g/dL, or other known bleeding diathesis
- Hemodynamically unstable during procedures or cardiogenic shock
- Pregnant women or women who might be pregnant
- Life expectancy; less than 1 year
- Inability to understand or read the informed content
Sites / Locations
- Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
OCT-guided PCI
Angiography-guided PCI
Arm Description
Patients will receive PCI under OCT-guidance.
Patients will receive PCI under Angiography-guidance.
Outcomes
Primary Outcome Measures
Composite of major adverse cardiac events (MACEs)
Composite of major adverse cardiac events (MACEs) - for comparison between OCT-guided PCI vs. angiography-guided PCI
Secondary Outcome Measures
Each component of MACE
MACE = composite of cardiac death, myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization
Any revascularization
Target lesion revascularization
Periprocedural myocardial infarction
Periprocedural MI - PCI-related myocardial infarction (>5x or >10x ULN)
Bleeding
Bleeding defined by BARC and TIMI criteria
Stroke
Stent thrombosis confirmed by OCT
The attainment(optimal or acceptable) of criteria regarding stent expansion is strongly recommended. As for the other criteria, further procedures could be decided by the operators' decisions considering the situations.
Stent expansion Optimal - meeting of all criteria Acceptable - meeting of any one criteria 1) MSA≥80% of mean reference lumen area 2) ≥100% of distal reference lumen area 3) MSA of >4.5 mm2 in non-left main lesion
Stent apposition Optimal - acute stent malposition<200μm Acceptable - acute stent malposition<400μm
Edge dissection(Definition of major edge dissection; any one of the followings) 1) ≥60°of the circumference of the vessel at site of dissection 2) Length of dissection ≥3mm 3) Deeper vessel injury(intramural hematoma or penetration to the media or adventitia)
Contrast-induced Nephropathy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03625908
Brief Title
Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
Official Title
Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
January 15, 2022 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is no definite conclusive work about the benefit of OCT-guided PCI, which should be determined in complex PCI, assuming better stent optimization by OCT. In the study, we will explore the clinical implication of OCT-guided PCI of complex lesions.
Detailed Description
Eligible patients will be randomly assigned to either OCT-guided PCI arm and angiography-guided PCI with routine high pressure NC ballooning arm in 1:1 ratio. Within OCT-guided PCI arm, the use of OCT will be also assigned to full OCT-guidance arm and postprocedural OCT only arm. and comparison of stent implantation with and without preprocedural OCT will be evaluated by postprocedural OCT (OCT-defined stent optimization will be assessed). In angiography-guided PCI arm, PCI for complex lesion will be performed without guidance of intravascular imaging, and routine use of high pressure postdilation with NC balloon will be also recommended. Primary endpoint will be evaluated during 12 months after PCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Optical coherence tomography, antiplatelet therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Patients will be assigned by use of OCT-guidance or angiography-guidance for stent implantation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1604 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OCT-guided PCI
Arm Type
Active Comparator
Arm Description
Patients will receive PCI under OCT-guidance.
Arm Title
Angiography-guided PCI
Arm Type
Active Comparator
Arm Description
Patients will receive PCI under Angiography-guidance.
Intervention Type
Device
Intervention Name(s)
OCT-guided PCI
Intervention Description
Patients will receive PCI under OCT-guidance. Predefined criteria for optimization of PCI under OCT-guidance will be recommended to achieve as far as possible.
Intervention Type
Device
Intervention Name(s)
Angiography-guided PCI
Intervention Description
Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter.
Primary Outcome Measure Information:
Title
Composite of major adverse cardiac events (MACEs)
Description
Composite of major adverse cardiac events (MACEs) - for comparison between OCT-guided PCI vs. angiography-guided PCI
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Each component of MACE
Description
MACE = composite of cardiac death, myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization
Time Frame
1 year (except periprocedural MI - within 48 hours)
Title
Any revascularization
Time Frame
1 year (except periprocedural MI - within 48 hours)
Title
Target lesion revascularization
Time Frame
1 year (except periprocedural MI - within 48 hours)
Title
Periprocedural myocardial infarction
Description
Periprocedural MI - PCI-related myocardial infarction (>5x or >10x ULN)
Time Frame
1 year (except periprocedural MI - within 48 hours)
Title
Bleeding
Description
Bleeding defined by BARC and TIMI criteria
Time Frame
1 year (except periprocedural MI - within 48 hours)
Title
Stroke
Time Frame
1 year (except periprocedural MI - within 48 hours)
Title
Stent thrombosis confirmed by OCT
Description
The attainment(optimal or acceptable) of criteria regarding stent expansion is strongly recommended. As for the other criteria, further procedures could be decided by the operators' decisions considering the situations.
Stent expansion Optimal - meeting of all criteria Acceptable - meeting of any one criteria 1) MSA≥80% of mean reference lumen area 2) ≥100% of distal reference lumen area 3) MSA of >4.5 mm2 in non-left main lesion
Stent apposition Optimal - acute stent malposition<200μm Acceptable - acute stent malposition<400μm
Edge dissection(Definition of major edge dissection; any one of the followings) 1) ≥60°of the circumference of the vessel at site of dissection 2) Length of dissection ≥3mm 3) Deeper vessel injury(intramural hematoma or penetration to the media or adventitia)
Time Frame
1 year (except periprocedural MI - within 48 hours)
Title
Contrast-induced Nephropathy
Time Frame
1 year (except periprocedural MI - within 48 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Age 19-85 years
Patients with ischemic heart diseases (including stable angina, unstable angina and acute myocardial infarction) presented with typical chest pain or objective evidences of myocardial ischemia (positive invasive or non-invasive studies, electrocardiogram (ECG) consistent with ischemia, or elevated cardiac enzymes)
Complex coronary stenotic lesions (>50% based on visual estimate) considered for coronary revascularization with DES
Definition of complex lesions (at least one):
Acute myocardial infarction
Chronic total occlusion
Long lesion: expected stent length ≥28mm based on angiographic estimation
Calcified lesion
Bifurcation (including all techniques, one- or two-stent)
Unprotected left main disease
Small vessel diseases with reference vessel diameter less than 2.5 mm
Intracoronary thrombus visible on the angiography
Stent thrombosis
In-stent restenosis
Patients who provide signed informed consent
Exclusion criteria
Severe hepatic dysfunction (≥3 times normal reference values)
Significant renal dysfunction (Serum creatinine >2.0 mg/dL)
Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a white blood cell count of <3,000 cells/mm3, hemoglobin <8.0 g/dL, or other known bleeding diathesis
Hemodynamically unstable during procedures or cardiogenic shock
Pregnant women or women who might be pregnant
Life expectancy; less than 1 year
Inability to understand or read the informed content
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Soo Jang, MD, Ph.D
Phone
+82-2-2228-8210
Email
jangys1212@yuhs.ac
Facility Information:
Facility Name
Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Soo Jang, MD, PhD
Email
jangys1212@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
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